Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

A Multi-center, Double-Blind, Randomized, Two-Arm, Parallel-Group, Placebo Controlled Study to Assess the Efficacy and Safety of ELGN-2112 on Intestinal Malabsorption in Preterm Infants

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05670951

Enrollment

360

Registered

2023-01-04

Start date

2025-02-27

Completion date

2029-05-01

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Malabsorption

Brief summary

The study will evaluate the effect of ELGN-2112 on intestinal malabsorption in preterm infants.

Interventions

DRUGELGN-2112

Human insulin \[rDNA\]

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

1 Days to 5 Days

Healthy volunteers

Inclusion criteria

* Male or female pre-term infant 26 and up to 32 weeks gestation. Gestational age matching (±2 weeks) between maternal dates and/or early antenatal ultrasound * Birth weight ≥ 500g * Singleton or twin birth

Exclusion criteria

Design outcomes

Primary

Measure	Time frame
Numbers of days to achieve full enteral feeding	28 days or discharge from hospital

Countries

Israel

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026